- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352644
Factors Affecting Attachment Loss in Clear Aligner Treatment
January 12, 2026 updated by: Şerife Şahin, Bezmialem Vakif University
Factors Affecting Attachment Loss in Clear Aligner Treatment: A Prospective Clinical Study
This prospective clinical study evaluated the incidence of composite attachment loss in patients undergoing clear aligner treatment and identified patient-, tooth-, and treatment-related factors associated with attachment debonding.
Twenty-one patients were followed for six months, and attachment failures were recorded at routine visits.
Outcomes were compared according to attachment type (conventional vs. optimized), attachment size, tooth type, dental arch, and patient-related factors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Composite attachments are integral to clear aligner therapy for improving force delivery, retention, and control of complex tooth movements.
Despite their biomechanical importance, attachment loss remains a common clinical challenge and may compromise treatment efficiency and predictability.
In this prospective study, attachments were bonded following the manufacturer's protocol using a high-viscosity composite.
Patients were followed for six months, and attachment failures were documented with respect to type, size, tooth position, and patient-related behaviors.
The primary objective was to determine the incidence of attachment loss and to identify factors associated with debonding, thereby contributing to clinical strategies that may reduce attachment failure and enhance treatment outcomes.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34093
- Bezmialem Vakif University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Permanent dentition. Mild to moderate crowding. No history of previous orthodontic treatment with fixed appliances or clear aligners
Exclusion Criteria:
Poor oral health. Bruxism. Crown restorations. Dental fluorosis. Enamel hypoplasia or other structural abnormalities affecting attachment bonding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clear Aligner Treatment
Participants received clear aligner therapy (Invisalign®) with composite attachments bonded according to the manufacturer's protocol.
Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated over a 6-month follow-up period.
|
Participants received clear aligner therapy (Invisalign®, Align Technology, San Jose, CA, USA).
Composite attachments were bonded according to the manufacturer's protocol using a high-viscosity composite.
Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated during a 6-month follow-up period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attachment Loss Rate
Time Frame: 6 months
|
Proportion of composite attachments exhibiting complete detachment or partial debonding (irregular residual composite) during routine follow-up visits.
Attachment loss was assessed by direct intraoral examination and tactile verification using a dental explorer.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
January 12, 2026
First Submitted That Met QC Criteria
January 12, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 12, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/19 (Other Identifier: Bezmialem Vakif University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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